WO2015154254A1

WO2015154254A1 - Gender specific synthetic nutritional compositions and nutritional systems comprising them

Info

Publication number: WO2015154254A1
Application number: PCT/CN2014/074993
Authority: WO
Inventors: Michael Affolter; Sagar THAKKAR; Carlos Antonio DE CASTRO
Original assignee: Nestle China Ltd
Current assignee: Nestle China Ltd
Priority date: 2014-04-09
Filing date: 2014-04-09
Publication date: 2015-10-15
Anticipated expiration: 2016-10-09
Also published as: RU2016143871A3; US20170035088A1; RU2704227C2; PH12016501919A1; MX389070B; AU2015245728A1; AU2015245728A2; EP3131416A4; AU2015101939A6; PH12016501919B1; EP3131416A1; CN106455659A; WO2015154659A1; MX2016012555A; US20200054062A1; RU2019132115A; RU2016143871A; AU2015101939A4

Abstract

Gender specific synthetic nutritional compositions for infants 4 to 8 months of age, 1 to 2 months of age, or up to 1 month of age wherein, the concentration of methionine is adapted based on that found in HM produced for an infant of the same gender and age, and nutritional systems comprising them.

Description

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Title:Gender specific synthetic nutritional compositions and nutritional systems comprising them.

Technical field:The invention relates to gender specific synthetic nutritional compositions, to nutritional systems comprising them and, to their use to provide optimised nutrition and/or one ormorehealthbenefittoaninfant.

Background of the invention

Even though breastfeeding is optimal for infants, existence of certain conditions may not be in the best interests of the infant and it may contraindicate breastfeeding (AAP, 2012; Lawrence, 2013). In such cases, where the sole source of nutrition is not available to the infant, alternative strategies to feed them have to be devised. Feeding infants with Synthetic nutritional compositions e.g. Infant formula is one such strategy.

The compositions of the aforementioned synthetic nutritional compositions are modeled on those of human milk. However, the composition of HM is extremely dynamic and these dynamic changes remain largely unexplored and uncharacterized. Whilst it is known that components and/or their quantities may vary depending on a variety of factors including the stage of lactation, circadian rhythms and even gender, it is not known which of the numerous components vary and if so how they vary e.g. by stage of lactation and/or gender.

Surprisingly it has now been identifiedthat 4 to 8 months, 1 to 2 months, and up to 1 month, more particularly 2 weeks to 1 month, postpartum, there is a difference in the methionine concentration range found in HM produced by mother’s to girls in comparison to mother’s to boys . This finding stems from a cross-sectional study of HM wherein, HM samples from mothers to either boys or girls were collected at various stages postpartum and analysed. Further, it was also surprisingly found that 4 to 8 months and up to 1 month, more particularly 2 weeks to 1 month, postpartum the methionine concentration in HM produced by mothers to boys was higher than that produced for mothers to girls. Conversely, it was also surprisingly found that 1 to 2 months postpartum the methionine concentration in HM produced by mothers to boys was lower than that produced for mothers to girls Because these gender differences in the concentration of methionine in HM have never been previously identified,they are not reflected in the compositions of synthetic nutritional compositions available today.

Methionine is an amino acids.An optimum intake of amino acids helps to ensure optimum growth and development in infants.

Optimum growth and development may be immediate and/or long term.Long term may only be evident in months or years e.g.6months,9months,12months,5years,10years,or20 years.

Accordingly,there remains a need for gender specific synthetic nutritional compositions,and nutritional systems comprising them,having compositions within which the identified gender differences,with respect to concentration ranges of methionine,found in HM4to8months,1 to2months,and up to1month,more particularly2weeks to1month,postpartum are more accurately reflected and thereby optimised.

Summary of the invention

The invention is set out in the claims.The inventors have found that the concentration ranges of methionine in HM varies4to8months,1to2months,and up to1month,more particularly 2weeks to1month,postpartum depending on the gender of the mother’s infant.In light of this finding the inventors have developed gender specific nutritional compositions and nutritional systems comprising them,that reflect these identified gender differences.Prior to aforementioned findings the skilled person has not incentive to develop such gender specific synthetic nutritional compositions or to include them in nutritional systems.

The concentration of methionine in the gender specific synthetic nutritional compositions of the invention,and nutritional systems comprising them,more accurately reflect the concentration of methionine found in HM produced for infants of the same gender and age.In light of this and, because HM is considered optimal with respect to infant nutrition,they can provide an optimized amount of methionine to an infant of4to8months,1to2months of age,and up to 1month of age,more particularly2weeks to1month of age.

The gender specific synthetic nutritional compositions can be prepared from a gender neutral synthetic nutritional composition by measuring out an appropriate amount of said gender neutral synthetic nutritional composition and mixing it with an additive and/or diluent.

Since optimised methionine intake is helps to ensure the optimum growth and development of an infant,the gender specific synthetic nutritional compositions,and nutritional systems of the invention,can also be used to treat,prevent or mitigate sub optimal growth e.g.obesity of an infant.

Optionally the gender specific synthetic nutritional composition is selected from the group consisting of:infant formula and a composition for infants that is intended to be added or diluted to human milk e.g.HM fortifier.

In addition to that set out above,the inventors have also found that the mean concentration of methionine in HM does not vary by gender2to4months postpartum.In light of this,in addition to comprising the gender specific synthetic nutritional compositions of the invention,the nutritional systems disclosed herein may optionally also comprise synthetic nutritional compositions for infants of2to4months of age wherein,the concentration of methionine does not differ by gender.Accordingly,the nutritional systems of the invention may provide optimized nutrition and/or one or more health benefits for an infant up to12months of age,up to9months of age,up to8months of age,up to6months of age.

Drawings

FIG.1is a graphical representation of the mean concentration of methionine in HM by gender at up to2weeks(5-11days),2weeks to1month(12-30days),1to2months(31to60days),2to 4months(61to120days),and4to8months(121to240days)postpartum.

Detailed Description

As stated herein,the inventors performed a cross sectional study evaluating the nutrient composition of HM collected from mothers at various stages of lactation(up to2weeks(5-11 days),2weeks to1month(12-30days),1to2months(31to60days),2to4months(61to120 days),and4to8months(121to240days)postpartum).The study indicated different min and max ranges for the concentration of ranges of methionine by gender.Surprisingly,the results of this study also indicated that4to8months,1to2months,and up to1month,more particularly2weeks to1month,postpartum,there is a difference in the concentration of methionine in HM depending on the gender of the mother’s infant.Further details of the study, analysis techniques and results are given in example1.

Based on the findings of the study,the inventors have designed gender specific synthetic nutritional compositions for infants of4to8months,1to2months,up to1month,more particularly2weeks to1month,of age wherein,the concentration of methionine is adapted based on that found in HM produced for an infant of the same gender and age.

The term“gender specific synthetic nutritional composition”as used herein refers to any synthetic nutritional composition,intended to be consumed by an infant that is specifically adapted to the nutritional needs of either a female or male enfant.

Non limiting examples of gender specific synthetic nutritional compositions for infants from birth to4months include;infant formulae,and a composition for infants that is intended to be added or diluted with HM e.g.HM fortifier.Non limiting examples of gender specific synthetic nutritional compositions for infants from4months to12months include infant formulae,a composition for infants that is intended to be added or diluted with HM e.g.HM fortifier,or food stuffs intended for consumption by infants either alone or in combination with HM e.g. complementary foods.

The term“infant”as used herein refers to a human infant of12months of age or less. In a first aspect of the invention there is provided a gender specific synthetic nutritional composition for an infant of4to8months of age,1to2months of age,up to1month of age, more particularly2weeks to1month of age,wherein,the concentration of methionine is adapted based on that found in HM produced for an infant of the same gender and age.

The gender specific synthetic nutritional composition can be a male specific synthetic nutritional composition or a female specific synthetic nutritional composition.

In an embodiment the gender specific synthetic nutritional composition is a female specific synthetic nutritional composition for an infant of4to8months of age and comprises methionine in a concentration of0.5mg to12mg,0.5mg to21.7mg,or10.65mg,per100g.

In an embodiment the gender specific synthetic nutritional composition is a male specific synthetic nutritional composition for an infant of4to8months of age and comprises methionine in a concentration of4.2mg to31.2mg,12.19mg to13.73mg,or13.73mg,per100g.

In an embodiment the gender specific synthetic nutritional composition is a female specific synthetic nutritional composition for an infant of up to1month,more particularly2weeks to1 month,of age and comprises methionine in a concentration of9.7mg to28.3mg,9.7mg to17mg, or16.67mg,per100g.

In an embodiment the gender specific synthetic nutritional composition is a male specific synthetic nutritional composition for an infant of up to1month,more particularly2weeks to1 month,of age and comprises methionine in a concentration of9.6mg to49.7mg,17.95mg to 49.7mg,30.84mg to49.7mg,,19.22mg,per100g.

In an embodiment the gender specific synthetic nutritional composition is a female specific synthetic nutritional composition for an infant of1to2months of age and comprises methionine in a concentration of4.8mg to30.2mg,13.29mg to30.2mg or15.05mg,per100g.

In an embodiment the gender specific synthetic nutritional composition is a male specific synthetic nutritional composition for an infant of1to2months of age and comprises methionine in a concentration of2.8mg to30.2mg,2.8mg to13mg,or13.73mg,per100g.

The concentration of methionine can be measured by methods well known in the art.In particular its concentration can be measured by an amino acid analyzer(using post-column derivatisation with ninhydrin)or by a pre-column derivatisation method(i.e.using PITC or OPA/FMOC chemistry as described in Blankenship D.T.et al.(1989)Analytical Biochemistry178: 227)followed by HPLC separation and quantification.

Any source of methionine known to be employed in the types of synthetic nutritional compositions disclosed herein may be comprised within in the gender specific synthetic nutritional compositions of the invention,in particular pure synthetic methionine obtained through synthesis or fermentation,or liberated from any food-grade protein source such as animal or plant proteins through hydrolysis.

The methionine may be intact,hydrolysed,partially hydrolysed,or any combination thereof.

Non limiting examples of such ingredients include:other amino acids,proteins,carbohydrates, oligosaccharides,lipids,prebiotics or probiotics,essential fatty acids,nucleotides,nucleosides, vitamins,minerals and other micronutrients.

Non limiting examples of other amino acids include,lysine,arginine,alanine,histidine, isoleucine,proline,valine,cysteine,glutamine,glutamic acid,glycine,serine,leucine,threonine, tyrosine,phenylalanine,tryptophane,asparagine,aspartic acid,and combinations thereof.

Non limiting examples of proteins include,caseins,alpha-lactalbumin,lactoferrin,serum albumin,whey,soy protein,rice protein,corn protein,oat protein,barley protein,wheat protein,rye protein,pea protein,egg protein,sunflower seed protein,potato protein,fish protein,meat protein,immunoglobins,and combinations thereof.

Non limiting examples of carbohydrates include lactose,saccharose,maltodexirin,starch,and combinationsthereof.

Non limiting examples of lipids include:palm olein,high oleic sunflower oil,high oleic safflower oil,canola oil,fish oil,coconut oil,bovine milk fat,and combinations thereof.

Non limiting examples of essential fatty acids include:linoleic acid(LA),α-linolenic acid(ALA) and polyunsaturated fatty acids(PUFAs).The nutritional compositions of the invention may further contain gangliosides monosialoganglioside-3(GM3)and disialogangliosides3(GD3), phospholipids such as sphingomyelin,phospholipids phosphatidylcholine, phosphatidylethanolamine,phosphatidylinositol,phosphatidylserine,and combinations thereof.

None limiting examples of prebiotics include:oligosaccharides optionally containing fructose, galactose,mannose;dietary fibers,in particular soluble fibers,soy fibers;inulin;and combinations thereof.Preferred prebiotics are fructo-oligosaccharides(FOS),galacto- oligosaccharides(GOS),isomalto-oligosaccharides(IMO),xylo-oligosaccharides(XOS),arabino- xylo oligosaccharides(AXOS),mannan-oligosaccharides(MOS),oligosaccharides of soy, glycosylsucrose(GS),lactosucrose(LS),lactulose(LA),palatinose-oligosaccharides(PAO),malto- oligosaccharides,gums and/or hydrolysates thereof,pectins and/or hydrolysates thereof,and combinations of the foregoing.

Further examples of oligosaccharide are described in Wrodnigg,T.M.;Stutz,A.E.(1999)Angew. Chem.Int.Ed.38:827-828and in WO2012/069416which is incorporated herein by reference.

Non limiting examples of probiotics include:Bifidobacterium,Lactobacillus,Lactococcus, Enterococcus,Streptococcus,Kluyveromyces,Saccharoymces,Candida,in particular selected from the group consisting of Bifidobacterium longum,Bifidobacterium lactis,Bifidobacterium animalis,Bifidobacterium breve,Bifidobacterium infantis,Bifidobacterium adolescentis, Lactobacillus acidophilus,Lactobacillus casei,Lactobacillus paracasei,Lactobacillus salivarius, Lactobacillus lactis,Lactobacillus rhamnosus,Lactobacillus johnsonii,Lactobacillus plantarum, Lactobacillus salivarius,Lactococcus lactis,Enterococcus faecium,Saccharomyces cerevisiae, Saccharomyces boulardii or mixtures thereof,preferably selected from the group consisting of Bifidobacterium longum NCC3001(ATCC BAA-999),Bifidobacterium longum NCC2705(CNCM I- 2618),Bifidobacterium longum NCC490(CNCM I-2170),Bifidobacterium lactis NCC2818(CNCM I-3446),Bifidobacterium breve strain A,Lactobacillus paracasei NCC2461(CNCM I-2116), Lactobacillus johnsonii NCC533(CNCM I-1225),Lactobacillus rhamnosus GG(ATCC53103), Lactobacillus rhamnosus NCC4007(CGMCC1.3724),Enterococcus faecium SF68(NCC2768; NCIMB10415),and combinations thereof.

Non limiting examples of Nucleotides include:cytidine monophosphate(CMP),uridine monophosphate(UMP),adenosine monophosphate(AMP),guanosine monophosphate(GMP), andcombinationsthereof.

Non limiting examples of vitamins and minerals include:vitamin A,vitamin B1,vitamin B2, vitamin B6,vitamin Bi2,vitamin E.vitamin K.vitamin C,vitamin D,folic acid,inositol,niacin, biotin,pantothenic acid,choline,calcium,phosphorous,iodine,iron,magnesium,copper,zinc, manganese,chloride,potassium,sodium,selenium,chromium,molybdenum,taurine,L- carnitine,and combinations thereof.Minerals are usually added in salt form.

Other suitable and desirable ingredients of synthetic nutritional compositions,that may be employed in the gender specific nutritional compositions of the invention,are described in guidelines issued by the Codex Alimentarius with respect to the type of synthetic nutritional composition in question e.g.Infant formula,HM fortifier,follow on formula,and food stuffs intended for consumption by infants e.g.complementary foods.

The gender specific compositions of the invention may be prepared by methods well known in the art for preparing that type of synthetic nutritional composition e.g.infant formulae,follow on formulae,a composition for infants that is intended to be added or diluted with HM e.g.HM fortifier,and food stuffs intended for consumption by infants either alone or in combination with HM e.g.complementary foods.

An exemplary method for preparing a gender specific powdered infant formula is as follows. Amino acids(including methionine)and/or protein source(comprising bound methionine), carbohydrate source,and fat source may be blended together in appropriate proportions. Emulsifiers maybe included in the blend.Vitamins and minerals may be added at this point but are usually added later to avoid thermal degradation.Any lipophilic vitamins,emulsifiers and the like may be dissolved into the fat source prior to blending.Water,preferably water which has been subjected to reverse osmosis,may then be mixed in to form a liquid mixture.

The liquid mixture may then be thermally treated to reduce bacterial loads.For example,the liquid mixture may be rapidly heated to a temperature in the range of about80℃to about1 10℃for about5seconds to about5minutes.This may be carried out by steam injection or by heat exchanger;for example a plate heat exchanger.

The liquid mixture may then be cooled to about60℃to about85℃;for example by flash cooling. The liquid mixture may then be homogenised;for example in two stages at about7MPa to about40MPa in the first stage and about2MPa to about14MPa in the second stage.The homogenised mixture may then be further cooled to add any heat sensitive components such as vitamins and minerals.The pH and solids content of the homogenised mixture is conveniently standardised at this point.

The homogenised mixture can be transferred to a suitable drying apparatus such as a spray drier or freeze drier and converted to powder.The powder should have a moisture content of less than about3%by weight.

If it is desired probiotic(s)can be added,they may be cultured according to any suitable method and prepared for addition to the infant formula by freeze-drying or spray-drying for example. Alternatively,bacterial preparations can be bought from specialist suppliers such as Christian Hansen and Morinaga already prepared in a suitable form for addition to food products such as infant formula.Such bacterial preparations may be added to the gender specific powdered infant formula by dry mixing.

The gender specific compositions of the invention may also be prepared from a gender neutral synthetic nutritional composition in a method comprising;measuring out an appropriate amount of said gender neutral synthetic nutritional composition and mixing it with an additive and/or diluent e.g.water so as to arrive at a gender specific nutritional composition in accordancewiththeinvention.

The additive may be a gender specific additive comprising caseins in a particular concentration so that when mixed with the gender neutral synthetic nutritional composition,and optionally a diluent,the resulting mixture is a gender specific synthetic nutritional composition of the invention.

The gender neutral synthetic nutritional composition can be prepared by methods well known in the art.For example,as laid out above for infant formula.

One or more of the gender specific synthetic nutritional compositions of the invention can be included in a nutritional system.

The term“nutritional system”as used herein refers to a collection of more than one synthetic nutritional composition advertised or sold as part of the same product range e.g.a collection of infant formulas sold under the same brand and adapted to the nutritional needs of infants of differing genders and/or ages.The synthetic nutritional compositions making up the nutritional system may be packaged individually e.g.in capsules or boxes.Said packages can be sold individually,grouped together e.g.wrapped by plastic film or combined in a box,or in a combination of these two ways.

The nutritional system may comprise only gender specific synthetic nutritional compositions,or it may comprise a mix of gender specific and gender neutral synthetic nutritional compositions. The term“gender neutral”as used herein is synonymous with unisex.

In a further aspect of the present invention there is provided a nutritional system comprising at least one of the gender specific synthetic nutritional compositions of the invention.

In an embodiment the nutritional system comprises at least one gender specific synthetic nutritional composition for a male infant and at least one gender specific nutritional composition for a female infant wherein,said male and female gender specific synthetic nutritional compositions are for infants of the same age selected from the group consisting of:4 to8months of age,1to2months of age,up to1month of age,more particularly2weeks to1 month of age.

The herein referenced study indicated that the mean concentration of methionine comprised in HM produced for male infants of4to8months of age and up to1month of age,more particularly2weeks to1month of age,was higher than that produced for female infants of the same age.Conversely,the study indicated that mean concentration of methionine comprised in HM produced for male infants of1to2months of age was equal to or less than that produced for female infants of the same age.

In an embodiment the gender specific synthetic nutritional compositions,comprised within the nutritional system,are for infants of4to8months of age and up to1month of age,more particularly2weeks to1month of age,and the concentration of methionine in said male gender specific synthetic nutritional composition is higher than that of said female gender specific synthetic nutritional composition.

The concentration of methionine in the male gender synthetic nutritional compositions may be higher by any amount.

In an embodiment the ratio of the concentration of methionine between the female gender specific nutritional composition and male gender specific synthetic nutritional composition for infants of4months to8months of age is1:62.4to1:1.015,1:62.4to1:1.2;or1:8.4to1:1.43, and/or the male gender specific nutritional composition comprises30.7mg to0.001mg,30.7mg to3.08mg,or9.5mg to3.7mg more methionine per100g than the female gender specific nutritional composition.

In an embodiment the ratio of the concentration of methionine between the female gender specific nutritional composition and male gender specific synthetic nutritional composition for infants of up to1month of age,more particularly2weeks to1month of age,is1:5.2to1:1.055, 1:5.2to1:1.1;or1:1.75to1:1.15,and/or the male gender specific nutritional composition comprises40mg to0.0001mg,40mg to2.54mg,or21.4mg to2.54mg more methionine per 100g than the female gender specific nutritional composition.

In another embodiment the gender specific synthetic nutritional compositions,comprised within the nutritional system,are for infants of1to2months of age and the concentration of methionine in said male gender specific synthetic nutritional composition is lower than that of said female gender specific synthetic nutritional composition.

The concentration of methionine in the male gender synthetic nutritional compositions may be lower by any amount.

In another embodiment the nutritional system comprises male and female gender specific synthetic nutritional compositions for infants1to2months of age wherein,the ratio of the methionine concentration between the female gender specific nutritional composition and male gender specific synthetic nutritional composition is1:0.8to1:0.98,or1:0.8to1:0.5,and/or the female gender specific nutritional composition comprises3.6mg to0.001mg,or3.6mg to2mg more methionine per100g than the male gender specific nutritional composition.

In addition to that disclosed hereinabove,the referenced study further indicated that2to4 months,and up to2weeks postpartum there is no difference in the mean concentration of methionine in HM depending on the gender of the mother’s infant.

In another embodiment the nutritional system further comprises gender specific synthetic nutritional compositions for infants of up to2weeks of age and/or2months to4months of age wherein,the concentration of methionine does not differ by gender for infants of the same age.

In another embodiment the nutritional system further comprises gender neutral specific synthetic nutritional compositions for infants up to2weeks of age and/or2months to4months of age.

The nutritional system may further comprise nutritional compositions for infants older than8 months of age and children older than12months.

A gender specific synthetic nutritional composition and/or nutrition system according to the invention is particularly suitable for use in a method of preparing single servings of infant formula using capsules,each capsule of which contains a unit dose of a synthetic nutritional composition in concentrated form,and which is equipped with opening means contained within the capsule to permit draining of the reconstituted synthetic nutritional composition directly from the capsule into a receiving vessel such as a baby bottle.Such a method is described in WO2006/077259.

The different synthetic nutritional compositions,including gender specific and gender neutral synthetic nutritional compositions,which may be comprised within a nutrition system,may be packed into individual capsules and presented to the consumer in multipacks containing a sufficient number of capsules to meet the requirements of an infant of a particular age or age range,for one week for example.Suitable capsule constructions are disclosed in WO2003/059778.

The capsules can contain the synthetic nutritional compositions,(gender specific and gender neutral)in the form of powders or concentrated liquids in both cases for reconstitution by an appropriate amount of water.Both the composition and the quantity of infant formula in the capsules may vary according to the gender and/or age of the infant.If necessary,different sizes of capsules may be provided for the preparation of infant formulas for infants of different genders and/or ages.

The gender specific synthetic nutritional compositions,or nutritional systems comprising them, better reflect the differences in the concentration of methionine found in HM depending on the gender of the mother’s infant at one or more stages of lactation.As stated herein,optimum methionine intake helps to ensure the optimum growth and development of an infant..

In another aspect of the present invention there is provided a gender specific synthetic nutritional composition and/or nutritional system as disclosed herein,for use to treat,prevent or mitigate sub optimal growth of an infant e.g.obesity

A gender specific synthetic nutritional composition may provide an optimum amount of total methionine,to an infant4to8months of age,1to2months of age,or up to1month of age, more particularly2weeks to1month of age.

The nutritional system may provide an optimum amount of total methionine,to an infant up to 12months of age,up to9months of age,up to8months of age,up to6months of age,up to1 month of age.

In another aspect of the present invention there is provided a method for providing an optimum amount of methionineto an infant of4to8months of age,1to2months of age,or up to1 month of age,more particularly2weeks to1month of age comprising:

a)Optionally preparing a gender specific synthetic nutritional compositions according to the invention from a gender neutral synthetic nutritional composition;

b)Feeding a gender specific synthetic nutritional compositions according to the invention to an infant of4to8months of age,1to2months of age,or up to1month of age,more particularly2weeks to1month of age.

As stated herein.The gender specific synthetic nutritional compositions may be prepared from gender neutral synthetic nutritional compositions.Accordingly,in another aspect of the present invention there is provided a kit for providing an optimized amount of total methionineto an infant of4to8months of age,1to2months of age,or up to1month of age,more particularly 2weeks to1month of age,the kit comprising:

a)A gender neutral synthetic nutritional composition

b)A label indicating dosage requirements for an infant so as to arrive at a gender specific nutritional composition in accordance with the invention.

The dosage requirements may be with respect to the quantity of the gender neutral synthetic nutritional employed and/or consumption frequency e.g.4times per day.

Subjects included in the survey referenced herein were recruited from4provinces across China. Accordingly,the gender specific synthetic nutritional compositions and/or nutritional systems disclosed herein can be particularly relevant for Chinese infants,and or infants born in populations having common genetic origins and/or ethnic origins and/or common dietary habits thereto e.g.Asian,Indian,and/or Mongoloid populations.

It should be appreciated that all features of the present invention disclosed herein can be freely combined and that variations and modifications may be made without departing from the scope of the invention as defined in the claims.Furthermore,where known equivalents exist to specific features,such equivalents are incorporated as if specifically referred to in this specification.

There now follows a series of non-limiting examples that serve to illustrate the invention.

Examples

Example1

The concentration of methionine in HM samples collected from mothers to either male or females was analysed at various stages postpartum.The HM samples were collected as part of a cross sectional survey of HM.The study criteria is set out below:

Study population

·Number of subjects

Total540healthy subjects were enrolled,allowing a drop-out rate of10percent.They were comprised of:

–480Lactating mothers in3cities(Beijing,Suzhou and Guangzhou)

–30mothers per city for each of the5time points(5to11days,12to30days,1to2months,2 to4months,and4to8months)

Inclusion/Exclusion criteria

·Inclusion:Healthy Chinese lactating mothers without history of acute and chronic diseases; exclusively breast feeding mothers during4months after delivery were enrolled.

·Exclusion:Chinese lactating mothers having history of psychopathic tendencies and having no dietary memory.

The concentration of methionine in the HM samples collected as part of the above detailed study were analyzed using firstly acid hydrolysis in6M hydrochloric acid at110℃for22hrs with phenol antioxidant in the absence of oxygen to liberate all protein-bound methionine, followed secondly by high-sensitivity amino acid analysis using derivatisation with o- Phthalaldehyde(OPA)and9-Fluorenylmethyl Chloroformate(FMOC),and fluorescence detection(Blankenship D.T.et al.(1989)Analytical Biochemistry178:227).

The results of the compositional analysis of the HM survey,with respect to the concentration of methionineareshownintableI.

Table I

The results of the compositional analysis were then subject to a statistical analysis employing the following statistical model:

Concentration=sex+timeframe+timeframe+sex:timeframe–city+ε

εreferring to the residual error and sex:timeframe referring to the interaction between these2 variables.

The following table shows the estimates for gender differences per timeframe along with the corresponding Pvalues.

The results of the Statistical analysis(statistical inference)are show in in table II.

Table II

A P-value inferior to0.1for a particular timeframe suggests that there is a statistically significant difference in the concentration of methionine in HM produced for males and females infants at that specific timeframe.

As can be seen from the results in table II,a statistically significant difference in the concentration of methionine between HM produced for male and female infants was identified at4to8months,1to2months postpartum,and up to1month postpartum,more specifically 12to30days postpartum.No statistically significant difference was identified in the concentration of methionine between HM produced for male and female infants2to4months or less than2weeks(5-11days)postpartum.

Example2

Examples of gender specific infant formulas are given in table III

Table III

Example3

An example of a nutritional system in accordance with the invention is given in table IV.

Table IV

Claims

A gender specific synthetic nutritional composition for an infant4to8months of age,1 to2months of age,or up to1month of age wherein,the concentration of methionine is adapted based on that found in human milk produced for an infant of the same gender and age.
A gender specific synthetic nutritional composition according to claim1wherein,the concentration of methionine is adapted to an infant of4to8months of age and wherein, if the concentration of methionine is adapted to a male infant it is4.2to31.2,mg per 100g and,if the concentration of methionine is adapted to a female infant it is0.5to 21.7,mg per100g.
A gender specific synthetic nutritional composition according to claim1wherein the concentration of methionine is adapted to an infant of1to2months of age and wherein, if the concentration of methionine is adapted to a male infant it is2.8to30.2,mg per 100g and,if the concentration of methionine is adapted to a female infant it is4.8to 30.2,mg per L.
A gender specific synthetic nutritional composition according to claim1wherein the concentration of methionine is adapted to an infant of up to1month of age wherein,if the concentration of methionine is adapted to a male infant it is9.6to49.7mg per100g and,if the concentration of methionine is adapted to a female infant it is9.7to28.3mg per100g.
A composition according to anyone of claims1to4wherein the gender specific synthetic nutritional composition is selected from the groups consisting of:infant formula,and a composition for infants that is intended to be added to or diluted with human milk.
A method of preparing a composition as defined in any one of claims1to5comprising: measuring out an appropriate amount of a gender neutral synthetic nutritional composition and mixing it with an additive and/or diluent.
A nutritional system comprising a gender specific synthetic nutritional composition as defined in any one of claims1to5.
A nutritional system according to claim7comprising at least one gender specific synthetic nutritional composition for a male infant as defined in any one of claims1to5 and at least one gender specific nutritional composition for a female infant as defined in any one of claims1to5wherein,said male and female gender specific synthetic nutritional compositions are for infants of the same.
A nutritional system according to claim8wherein,if the nutritional system comprises male and female gender specific synthetic nutritional compositions for infants4to8 months of age as defined in claim1or2,the concentration of methionine in the male gender specific nutritional composition is higher than that for the female gender specific synthetic nutritional composition.
A nutritional system according to claim8wherein,if the nutritional system comprises male and female gender specific synthetic nutritional compositions for infants up to1 month of age as defined in claim1or3,the concentration of methionine in the male gender specific nutritional composition is higher than that for the female gender specific synthetic nutritional composition.
A nutritional system according to claim8wherein,if the nutritional system comprises male and female gender specific synthetic nutritional compositions for infants1to2 months of age as defined in claim1or4,the concentration of methionine in the female gender specific nutritional composition is higher than that for the male gender specific synthetic nutritional composition.
A nutritional system according to any one of claims7to11further comprising gender specific synthetic nutritional compositions for infants of2to4months of age wherein, the concentration of methionine in said gender specific synthetic nutritional compositions does not differ by gender for infants of the same age.
A nutritional system according to any one of claims7to11further comprising gender neutral synthetic nutritional compositions for infants of2to4months of age.
Use of a gender specific synthetic nutritional composition as defined in anyone of claims 1to5to provide an optimum amount of methionine to a male or female infant of4to8 months of age,1to2months of age,or up to1month of age.
A gender specific synthetic nutritional composition as defined in anyone of claims1to5 for use to treat,protect or mitigate sub optimal growth and development of an infant.
A method for providing an optimum amount of methionine to an infant of4to8months of age,1to2months of age,or up to1month of age,comprising:

a.Optionally preparing a gender specific nutritional compositions as defined in any one of claims1to5from a gender neutral synthetic nutritional composition;

b.Feeding a a gender specific nutritional compositions as defined in any one of claims1to5to an infant of4to8months of age,1to2months of age,or up to1 month of age.
A nutritional system as defined in anyone of claims7to13for use to treat,protect or mitigate sub optimal growth and development of an infant.
A kit for providing an optimized amount of total methionine to an infant of up to4to8 months age,1to2months of age,or up to1months of age,the kit comprising:

a.A gender neutral synthetic nutritional composition

b.A label indicating dosage requirements for an infant so as to arrive at a gender specific nutritional composition as defined in any one of claims1to5.